Oculis Announces Phase 2 Results for Licaminlimab in Dry Eye Disease, Despite Limited Statistical Significance

1. Oculis Announces Phase 2 Results: Oculis has announced the results of its Phase 2 clinical trial for licaminlimab (OCS-02) in treating dry eye disease, but most of the data did not reach statistical significance.
2. Licaminlimab Mechanism of Action: Licaminlimab is a single-chain antibody fragment (scFv) that binds to and neutralizes the activity of human TNFα, with a dual mechanism of action involving anti-inflammation and anti-angiogenesis.
3. Phase 2 Trial Details: The trial was double-blinded, multicenter, and placebo-controlled, assessing the effect of topical licaminlimab on global ocular discomfort scores in patients with dry eye disease.
4. Primary Endpoint: The primary endpoint, the change in global ocular discomfort score from baseline to Day 29, was statistically significantly greater for licaminlimab compared to the vehicle (-7.9 vs. -3.6, p = 0.041).
5. Secondary Endpoints: While most secondary endpoints did not reach statistical significance, one secondary endpoint showed a statistically significant improvement in the subpopulation with corneal inflammation.
6. Safety Profile: Licaminlimab was well tolerated, with no major safety differences compared to the vehicle and no increase in intra-ocular pressure observed.
7. Future Plans: Oculis plans to move forward with a Phase 3 trial, focusing on a subgroup of patients with corneal inflammation, where the treatment showed promise.